Human Immunodeficiency Virus I InfectionNCT06368453
A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test
A study testing INSTI® HIV Self-Test in people with Human Immunodeficiency Virus I Infection and Human Immunodeficiency Virus II Infection, run by bioLytical Laboratories at 1 site in United States.
Trial summary
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection
- What is being tested?
- INSTI® HIV Self-Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,728 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 8 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Operator/study staff must complete the subject's Enrolment Questionnaire
- Subject to sign and date the Informed Consent Form
- Able to complete the required testing on the allocated testing day(s).
- Able to speak/ read/write English or Spanish
- Willingness to provide the fingerstick blood sample and if necessary, the volume of whole blood collected through venous blood draw (approximately 7 ml)
- Willingness to participate in the study site's standard of care HIV counselling and testing program and receive the study site's standard of care test results
- Unknown HIV Status
Who cannot join
- Has participated in any prior, or concurrent trial of HIV self-tests
- Is a practicing medical healthcare professional (doctor, nurse or HIV Counsellor that performs HIV testing with Rapid Tests)
- Is currently on a PrEP regimen
- Has used a Rapid Diagnostic Test for HIV blood-based self-testing previously
- Has received any experimental HIV vaccine
- Has a bleeding disorder
Show all 9Show fewer
- Is known HIV+
- Uses Anti-Retroviral medication
- Any condition which, in the opinion of the Operator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome, i.e., being unable to see / read by forgetting to bring reading glasses, being intoxicated or acute sickness, or visibly distressed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
About this study
Official title: A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test When Performed by Observed Intended Users in the US
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing.
The study aims to:
Read more
To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.
Read the detailed description
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended user population across the United States (US). This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV self-testing.
The study aims to:
To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV ST in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.
Subjects will be consecutively enrolled from the 'general' population (i.e., "all comers" group of previously undiagnosed HIV individuals) until a minimum of 27 HIV positive and 1000-1700 HIV negatives are obtained. Subjects will be lay users recruited at multiple sites across the US. This study is to determine if lay users, unassisted, can perform the INSTI® HIV ST correctly and without significant risk of incorrect results. The study will help to determine if the INSTI® HIV ST instructions are easy to understand for the US public. The overall study processes include a performance evaluation, where subjects will perform the INSTI® HIV ST, a mock results interpretation study to assess the user's comprehension of the INSTI® HIV ST results and usability evaluation to understand users experience with the INSTI® HIV ST. Only a subset of the enrolled subjects (500 subjects) will participate in the mock results interpretation study and usability evaluation.
For the performance evaluation, subjects will perform the INSTI® HIV ST without any intervention from an observer. Following the subjects self-testing, an operator will collect an additional fingerstick sample to perform a comparator test. The positive and negative percent agreement (i.e., PPA and NPA) between the INSTI® HIV ST result and comparator will be calculated. In the event of discrepant results between the INSTI® HIV ST and comparator test, an additional venous blood sample will be collected from the subject for discrepancy testing.
A subset of the enrolled subjects will then participate in the mock results interpretation study and usability evaluation. For the mock study, the subjects will be presented with 5 mock INSTI® HIV ST devices with different results, and the subject's interpretation of each device will be recorded. The percentage of subjects who interpreted the mock results correctly for each result type will be calculated.
For the INSTI® HIV ST usability evaluation, the subjects will be presented with a questionnaire. The overall results of the questionnaire will be used to determine the percentage of subjects who found the INSTI® HIV ST easy to use.
- Being tested
- INSTI® HIV Self-Test
- Keywords
- HIV Self Test, INSTI HIV Self test, HIV-1/2 Antibody Test, In-Home HIV test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTI® HIV Self-TestDevice
Each participant will be provided with the INSTI® HIV Self-Test and asked to conduct self testing. The operator will observe the participant and record the subject's interpretation of the results. Subjects will perform the test without intervention from the operator.
The operator will then perform the comparator test and collect a fingerstick blood sample. In the event of a discrepant result between the INSTI® HIV ST and comparator test, an additional venous blood sample will be collected from the subject and sent for discrepancy testing.
| Study group | Role | What they receive |
|---|---|---|
| Performance | Experimental | INSTI® HIV ST devices are provided to the enrolled participants to conduct the self test using the provided instruction for use while being observed by an operator. The operator records the INSTI® HIV ST results interpreted by the subjects. The operator then performs the comparator test to compare the results with the INSTI® HIV ST. Receives: Device: INSTI® HIV Self-Test |
| Mock results interpretation study and Usability evaluation | No intervention | A subset of the enrolled subjects (500 subjects) will participate in the mock results interpretation study and usability evaluation. For the mock study, the subjects will be presented with 5 mock INSTI® HIV ST devices with different results, and the subject's interpretation of each device will be recorded. The percentage of subjects who interpreted the mock results correctly for each result type will be calculated. For the INSTI® HIV ST usability evaluation, the subjects will be presented with a questionnaire. The overall results of the questionnaire will be used to determine the percentage of subjects who found the INSTI® HIV ST easy to use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sensitivity and specificity of the INSTI® HIV Self-Test
The positive percent agreement (PPA) and negative percent agreement (NPA) between the INSTI® HIV ST and comparator test will be determined. The two-sided confidence interval for the PPA and NPA will be determined.
The percentage of assays with INSTI® HIV ST invalid results will be determined.
Measured: 12 Months
Secondary outcomes (1)
The INSTI® HIV Self-Test usability and result interpretation
The percentage of subjects who interpreted the INSTI® HIV ST mock results correctly for each result type will be determined.
The usability questionnaire will be used to determine the following:
The percentage of subjects who found the INSTI® HIV ST easy to use. The percentage of subjects who found the INSTI® HIV ST product information easy to use.
The percentage of subjects willing to use the INSTI® HIV ST again The percentage of subjects willing to recommend the INSTI® HIV ST
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start2 May 2024
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus I InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,728 participants (actual)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven A Geller, Principal investigator, Centennial Medical GroupAnthony LaMarca, Principal investigator, Therafirst Medical Centers Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368453
- Sponsor's protocol ID
- CLS-003
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test When Performed by Observed Intended Users in the US
- ClinicalTrials.gov ID
- NCT06368453
- Acronym / sponsor ID
- CLS-003
- Keywords
- HIV Self Test, INSTI HIV Self test, HIV-1/2 Antibody Test, In-Home HIV test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,728 participants (actual)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 2 May 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing.
The study aims to:
To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.
Detailed description
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended user population across the United States (US). This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV self-testing.
The study aims to:
To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV ST in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.
Subjects will be consecutively enrolled from the 'general' population (i.e., "all comers" group of previously undiagnosed HIV individuals) until a minimum of 27 HIV positive and 1000-1700 HIV negatives are obtained. Subjects will be lay users recruited at multiple sites across the US. This study is to determine if lay users, unassisted, can perform the INSTI® HIV ST correctly and without significant risk of incorrect results. The study will help to determine if the INSTI® HIV ST instructions are easy to understand for the US public. The overall study processes include a performance evaluation, where subjects will perform the INSTI® HIV ST, a mock results interpretation study to assess the user's comprehension of the INSTI® HIV ST results and usability evaluation to understand users experience with the INSTI® HIV ST. Only a subset of the enrolled subjects (500 subjects) will participate in the mock results interpretation study and usability evaluation.
For the performance evaluation, subjects will perform the INSTI® HIV ST without any intervention from an observer. Following the subjects self-testing, an operator will collect an additional fingerstick sample to perform a comparator test. The positive and negative percent agreement (i.e., PPA and NPA) between the INSTI® HIV ST result and comparator will be calculated. In the event of discrepant results between the INSTI® HIV ST and comparator test, an additional venous blood sample will be collected from the subject for discrepancy testing.
A subset of the enrolled subjects will then participate in the mock results interpretation study and usability evaluation. For the mock study, the subjects will be presented with 5 mock INSTI® HIV ST devices with different results, and the subject's interpretation of each device will be recorded. The percentage of subjects who interpreted the mock results correctly for each result type will be calculated.
For the INSTI® HIV ST usability evaluation, the subjects will be presented with a questionnaire. The overall results of the questionnaire will be used to determine the percentage of subjects who found the INSTI® HIV ST easy to use.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performance | Experimental | Device: INSTI® HIV Self-TestINSTI® HIV ST devices are provided to the enrolled participants to conduct the self test using the provided instruction for use while being observed by an operator. The operator records the INSTI® HIV ST results interpreted by the subjects. The operator then performs the comparator test to compare the results with the INSTI® HIV ST. |
| Mock results interpretation study and Usability evaluation | No intervention | –A subset of the enrolled subjects (500 subjects) will participate in the mock results interpretation study and usability evaluation. For the mock study, the subjects will be presented with 5 mock INSTI® HIV ST devices with different results, and the subject's interpretation of each device will be recorded. The percentage of subjects who interpreted the mock results correctly for each result type will be calculated. For the INSTI® HIV ST usability evaluation, the subjects will be presented with a questionnaire. The overall results of the questionnaire will be used to determine the percentage of subjects who found the INSTI® HIV ST easy to use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Operator/study staff must complete the subject's Enrolment Questionnaire
- Subject to sign and date the Informed Consent Form
- Able to complete the required testing on the allocated testing day(s).
- Able to speak/ read/write English or Spanish
Key exclusion criteria (9 listed)
- Has participated in any prior, or concurrent trial of HIV self-tests
- Is a practicing medical healthcare professional (doctor, nurse or HIV Counsellor that performs HIV testing with Rapid Tests)
- Is currently on a PrEP regimen
- Has used a Rapid Diagnostic Test for HIV blood-based self-testing previously
- Has received any experimental HIV vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSTI® HIV Self-TestEach participant will be provided with the INSTI® HIV Self-Test and asked to conduct self testing. The operator will observe the participant and record the subject's interpretation of the results. Subjects will perform the test without intervention from the operator. The operator will then perform the comparator test and collect a fingerstick blood sample. In the event of a discrepant result between the INSTI® HIV ST and comparator test, an additional venous blood sample will be collected from the subject and sent for discrepancy testing. | Device | Performance |
Primary outcome
Clinical sensitivity and specificity of the INSTI® HIV Self-Test
Time frame: 12 Months
The positive percent agreement (PPA) and negative percent agreement (NPA) between the INSTI® HIV ST and comparator test will be determined. The two-sided confidence interval for the PPA and NPA will be determined. The percentage of assays with INSTI® HIV ST invalid results will be determined.
1 secondary outcome
The INSTI® HIV Self-Test usability and result interpretation
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven A Geller principal investigator
Centennial Medical Group
Anthony LaMarca principal investigator
Therafirst Medical Centers Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSTI® HIV Self-Test in people with Human Immunodeficiency Virus I Infection and Human Immunodeficiency Virus II Infection, run by bioLytical Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical sensitivity and specificity of the INSTI® HIV Self-Test (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.